| Methods |
Single‐site study
Randomization: sealed envelopes
Blinding: patients, providers |
| Participants |
Geographic region: Italy
Study setting: community
N = 22
Baseline IPSS: NR
Baseline prostate volume: NR
Mean age (range): 68.0 (54 to 78) years
Race: White
Diagnostic criteria: Men with symptomatic BPH not in need of surgery |
| Interventions |
Control: matching placebo
Treatment: Permixon® 160 mg twice daily
Study duration: 8.5 weeks
Lost to follow‐up: n = 0 |
| Outcomes |
Dysuria (4‐point scale)
Peak urine flow
Mean urine flow
Voiding time
Total voided volume
Pollachiuria
Dropouts due to side effects: not reported |
| Notes |
Exclusions: cancer; currently on other medication; urinary tract infection. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
not stated |
| Allocation concealment (selection bias) |
Unclear risk |
not stated |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
not stated |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
not stated |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
adequate |
| Selective reporting (reporting bias) |
Unclear risk |
unclear |
| Other bias |
Low risk |
adequate |
